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FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System ...[ Price : $8.95]
FDA posts a six-item Form FDA-483 after inspecting Hetero Labs Vishakapatnam, India, warehouse last month.[ Price : $8.95]
FDA approves an expanded indication for Mercks pulmonary arterial hypertension therapy Winrevair (sotatercept-csrk), clearing the ...[ Price : $8.95]
FDA clears a YorLabs 510(k) for its new intracardiac imaging system that the company says could reshape workflows in catheterizati...[ Price : $8.95]
FDA sends Sydnexis a complete response letter for SYD-101, a low-dose atropine eye-drop candidate intended to slow disease progres...[ Price : $8.95]
FDA grants Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use in treating cholangiocarcino...[ Price : $8.95]
Inhibrx Biosciences reports favorable data for treating chondrosarcoma with its antibody therapy ozekibart (INBRX-109).[ Price : $8.95]
FDA posts a two-item Form FDA-483 from an August inspection of Sumitomo Pharmas Suzuka, Japan, manufacturing facility.